The Project Director is responsible for oversight of the conduct of a program or portfolio of clinical studies or large global multicentered trials with large study budgets. The portfolio may comprise studies for specific customers, and/or a group of studies within the same therapeutic area or indication for more than one customer. The Project Director oversees Project Managers (PMs) who are managing projects ranging in size and complexity from single service studies to large full scope, multiple protocol projects, global projects and/or portfolio of projects. The Project Director leads the operational contribution to proposal development and business development activities at a project level with minimal oversight directly applying their therapeutic and project management expertise
This role will be perfect for you if:
- You are looking to contribute your expertise to the growth of a specialized CRO
- You are a hands-on leader
- You have at least 10 years of clinical project management experience, including management of all projects phases from start up to closure, management of all functional services, vendor management.
- You have experience in dermatology or rheumatology trials is required
RESPONSIBILITIES
- Oversees a portfolio or program of projects and the Project Managers assigned to operationalize the awarded studies.
- Ensures all studies within a program or portfolio are conducted to reflect the therapeutic or client specific requirements.
- Represents company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively.
- Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) or appropriate regulatory requirements, and International Conference on Harmonization (ICH) guidelines to fulfil all federal and local regulations.
- Oversees the management of the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses.
- Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
- Ensures and maintains an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio.
- Applies study specific learning across assigned portfolio of studies/clients.
- Leads and ensures consistency in contingency planning and risk mitigation strategies to ensure successful delivery.
- May lead operational input to proposal development and pricing including proposed operations strategy
- Drives performance improvement, operational efficiencies and innovative strategies
- May provide line management oversight and contribute to leadership of Project Management as an operational and therapeutic area expert
IDEAL PROFILE
Education
- Bachelor of Science in a relevant discipline.
- A Master’s degree is an asset.
- PMP or PRINCE2 Certification is an asset
Experience
- At least 15 years industry experience and a minimum of 5 years at a CRO
- At least 10 years of clinical project management experience, including management of all projects phases from start up to closure, management of all functional services, vendor management. Experience with mid-size and large studies (>10-15 countries) in multiple regions (NA, SA, APAC, MENA, Europe) is desirable.
- Experience leading concurrent multi-centered, multinational phase III clinical trials including project budget financial tracking and forecasting
- Substantial experience in project supervision, mentoring and coaching project managers
- Substantial experience with business development tasks, such as development of proposals, client presentations, bid defense meetings, and the like
- Participation in mentoring and coaching of a representative number of project managers
- Dermatology or rheumatology experience is required
Knowledge and skills
- Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
Work location
Note that this opening is for a home-based position in Germany
Regular travel, which may include overnight trips and / or international travel is required as part of this role.
About Indero
Indero is a contract research organization (CRO) specialized in dermatology and Rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in Poland.
Skills Required
- Bachelor of Science in a relevant discipline
- Master's degree
- PMP or PRINCE2 certification
- At least 15 years industry experience
- Minimum of 5 years experience at a CRO
- At least 10 years clinical project management experience covering all project phases and vendor management
- Experience in dermatology or rheumatology clinical trials
- Experience leading multicentered, multinational Phase III trials with budget tracking and forecasting
- Experience with mid-size and large studies (>10-15 countries) across multiple regions (NA, SA, APAC, MENA, Europe)
- Substantial experience supervising, mentoring and coaching Project Managers
- Substantial business development experience (proposals, client presentations, bid defense)
- Good knowledge of Good Clinical Practices (GCP) and applicable Health Canada and FDA regulations/guidelines
- Legal authorization to work in Poland
- Willingness to travel regularly, including overnight and international travel
What We Do
As a CRO (Contract Research Organization) specialized in dermatology and rheumatology, we provide scientific guidance, accurate results and customer satisfaction. Our unique service offering combines specialized Contract Research Services, knowledge of dermatology sites in North America and Europe reach and the extended capabilities of a large clinical research site. The design and conduct of Phase I to Phase IV studies is our core expertise. Our specialized services include: • Study Design and Protocol Development • Submission to Regulatory Agencies and Central Ethics Committees • Regulatory Consulting • Trial Master Files Management • Project Management • Investigator / Site Selection • Patient Recruitment • Clinical Monitoring • Medical Monitoring • Pharmacovigilance • Data Management • Biostatistical Analysis • Clinical Study Report • Medical Writing / Publication Since 2000, Innovaderm has built a strong reputation for the quality of its research and the care offered to its study participants, its clients and its sites, often exceeding our client’s timeline expectations.
